The AIDPRO-CRC Trial

Summary

The AIDPRO-CRC trial aims to improve outcomes for patients undergoing surgery for colorectal cancer by using artificial intelligence (AI) to assist surgeons in risk assessment. The trial will evaluate whether AI can help surgeons better predict the risk of complications and death, leading to improved care, fewer complications, and better use of healthcare resources.

In this nationwide, randomized clinical trial, participants will be divided into two groups. One group will have their risk assessed by a surgeon using standard clinical methods, while the other group will have their risk assessed by a surgeon using AI assistance. Based on the risk level, patients will receive varying levels of perioperative care. The AI-assisted risk assessment aims to tailor the treatment more precisely to each patient's individual needs, precisely allocating care to those who need it to more efficiently allocate heath system resources while having no deterioration in patient outcomes.

The primary hypothesis is that AI-assisted risk assessment will lead to more efficient and economic patient care without a deterioration in patient outcomes. The trial also aims to explore clinician satisfaction with the platform and its perceived effect. This is paired with a substudy exploring the variability of suggested treatment plans by clinicians with and without access to the MDT presentation platform.

The trial will include patients at seven hospitals across Denmark, involving patients diagnosed with colorectal cancer who are scheduled for curative surgery. All patients will receive standard treatment according to national guidelines, with the only difference being the modality of risk assessment. For the evaluation of the clinicians satisfactory with the device and the substudy of variability of suggested treatment plans, the trial will enroll clinicians using the device.

This study is a researcher-initiated, nationwide, randomized clinical trial involving patients diagnosed with colorectal cancer across eight hospitals in Denmark. Participants will be randomly assigned to one of two groups: AI-assisted risk assessment or standard surgeon-led assessment. The intervention focuses on optimizing perioperative care based on individual risk levels determined by either AI or the surgeon's clinical judgment.

The study builds on a successful pilot project (AID-SURG) that showed promising results in reducing complications, hospital stays, and readmissions.

Conditions

• Colo-rectal Cancer

Interventions

DEVICE

AI augmented risk-stratification

A state-of-the-art artificial intelligence (AI) model called AIDPRO manual CRC is used as a decision support tool to estimate the 1-year mortality risk for each patient

OTHER

Expert-based Risk-stratification

Experienced colorectal surgeons assess patient risk based on clinical judgment and national guidelines.

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Zealand University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-24

Primary Completion

2027-02-01

Completion

2028-02-01

Countries

• Denmark

Study Locations